Quality & Metrology
Quality Management and Metrology for Precision Contract Manufacturing
Brunk’s quality system is structured to support precision contract manufacturing programs from initial design review through sustained high-volume production. The system is built around documented process control, in-house metrology, and a quality management framework that meets the requirements of both ISO 13485 for medical device manufacturing and ISO 9001 for general quality management. These certifications are not treated as separate compliance tracks. All of Brunk’s production operations, tooling, inspection, and documentation processes operate under a single integrated quality management system.
Quality at Brunk is applied at the process level, not only at the inspection stage. Defining critical-to-quality dimensions during DFM, controlling process parameters during production, and maintaining full traceability from raw material receipt through shipment are all functions of the same system. Inspection confirms that the process is performing as qualified. It does not substitute for process control.
Metrology Infrastructure
Brunk operates five dedicated metrology labs distributed across its production facilities. The equipment inventory includes three coordinate measuring machines (CMMs), four OGP Flash 500 optical measurement systems, four OGP Smart Scope 302 systems, one OGP Quest 450, and two OGP Smart Scope 250 systems. This combination of tactile CMM measurement and non-contact optical measurement gives Brunk the ability to inspect the full range of component geometries encountered in precision stamping and machining programs, including micro-scale features, thin-wall profiles, and complex formed geometries where physical contact probing would risk part deformation.
OGP optical systems use multi-sensor measurement combining telecentric optics, laser probes, and white light interferometry to measure two- and three-dimensional part features with high throughput and without the risk of surface damage from probe contact. These systems are particularly well suited to the thin-gauge stamped components and delicate implantable device parts that make up a significant portion of Brunk’s production volume. CMM measurement is used where feature geometry, datum relationships, or tolerance requirements call for tactile point measurement with full GD&T reporting.
All measurement equipment is maintained on a documented calibration schedule traceable to NIST standards. Measurement system analysis (MSA) studies are conducted on gauges and fixtures used for in-process inspection to confirm that measurement uncertainty is acceptable relative to the tolerance being controlled.
Statistical Process Control and In-Process Inspection
Brunk uses statistical process control (SPC) throughout its production operations to monitor key process variables and detect shifts in process performance before they result in out-of-tolerance parts. QC-Gage software is deployed at smart workstations on the production floor, allowing operators to enter measurement data in real time and receive immediate feedback on whether the process is running within control limits. Control charts are maintained for critical dimensions on active production programs, and out-of-control conditions trigger a defined response workflow that stops the process for investigation before additional parts are produced.
SPC data collected during production feeds into Brunk’s ongoing process capability reporting. Cp and Cpk values are documented for critical dimensions at first article and are tracked over the production life of the program. This data is available to customers as part of the program record and supports supplier quality audits and customer qualification activities.
Quality Management System
Brunk manages its quality system through IQS, an enterprise quality management software platform that provides all production and quality staff access to procedures, work instructions, process records, and inspection data at the point of use. IQS connects the program record across incoming material inspection, in-process data collection, first-article documentation, nonconformance tracking, and corrective and preventive action (CAPA) management. This connectivity means that a nonconformance identified at final inspection can be traced back through the process record to identify where in the production sequence the deviation originated.
For ISO 13485 programs, IQS supports the device history record requirements that medical device customers and FDA regulations impose. Lot traceability, process parameter records, inspection results, and material certifications are all maintained within the system and can be retrieved and compiled for customer audits or regulatory submissions.
First Article Inspection and Production Release
All new production programs at Brunk go through a formal first article inspection (FAI) process before production is released. FAI at Brunk is conducted against a documented inspection plan that identifies every characteristic to be measured, the measurement method to be used, and the acceptance criteria for each dimension. Dimensional results are reported in a balloon-drawing format with full measurement data, and the FAI package includes material certifications, process parameter records, and surface finish data where applicable.
For programs governed by customer-specific PPAP requirements or AS9102 first article inspection standards, Brunk structures the FAI package to meet those requirements. The FAI is reviewed by Brunk’s quality engineering team and by the customer before production release is authorized. Any dimension that does not meet specification triggers a disposition process that determines whether the condition requires a tooling correction, a process adjustment, or an engineering disposition before production proceeds.
